Chronic Obstructive Pulmonary DiseasePhase 2NCT01168310
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Fluticasone Propionate/Formoterol Fumarate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by Dey at 23 sites in United States.
Trial summary
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD. Read more about this study
- Who is it for?
- Ages 40 days and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Fluticasone Propionate/Formoterol Fumarate and Formoterol Fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to understand the requirements of the study and provide written informed consent
- A clinical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study
Who cannot join
- A clinical diagnosis of Asthma
- Other significant disease than COPD
- Subjects who radiation or chemotherapy within the previous 12 months
- Subjects who had any lung resection
- QTcB greater than 0.460 seconds
- History of illegal drug abuse or alcohol abuse within the past 5 years
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Investigative Site
Charlotte, North Carolina
Investigative Site
Clearwater, Florida
Investigative Site
Coeur d'Alene, Idaho
Investigative Site
DeLand, Florida
Investigative Site
Easley, South Carolina
Investigative Site
Fullerton, California
Investigative Site
Gaffney, South Carolina
Investigative Site
Greenville, South Carolina
Investigative Site
Greer, South Carolina
Investigative Site
Lawrenceville, Georgia
Investigative Site
Madisonville, Kentucky
Investigative Site
Medford, Oregon
Investigative Site
Phoenix, Arizona
Investigative Site
Raleigh, North Carolina
Investigative Site
San Antonio, Texas
Investigative Site
San Diego, California
Investigative Site
Spartanburg, South Carolina
Investigative Site
Spokane, Washington
Investigative Site
St Louis, Missouri
Investigative Site
Sunset, Louisiana
Investigative site
Sylvania, Ohio
Investigative Site
Tamarac, Florida
Invesigative Site
Union, South Carolina
About this study
Official title: A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Fluticasone Propionate/Formoterol Fumarate, Formoterol Fumarate, Placebo
- Keywords
- Pulmonary, Obstructive, lungs, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension
Formoterol FumarateDrug
Inhalation Solution
PlaceboDrug
Inhalation Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| 2 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| 3 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| 4 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| 5 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| 6 | Active comparator | Not described Receives: Drug: Formoterol Fumarate |
| 7 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
Measured: 12 Weeks
Secondary outcomes (1)
Incidence of adverse events (AEs)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168310
- Sponsor's protocol ID
- 191-090
- Status last verified
- May 2013
- First submitted
- 21 Jul 2010
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
- ClinicalTrials.gov ID
- NCT01168310
- Acronym / sponsor ID
- 191-090
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary, Obstructive, lungs, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| 2 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| 3 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| 4 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| 5 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| 6 | Active comparator | Drug: Formoterol Fumarate |
| 7 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand the requirements of the study and provide written informed consent
- A clinical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study
Key exclusion criteria (6 listed)
- A clinical diagnosis of Asthma
- Other significant disease than COPD
- Subjects who radiation or chemotherapy within the previous 12 months
- Subjects who had any lung resection
- QTcB greater than 0.460 seconds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension | Drug | 1 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension | Drug | 2 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension | Drug | 3 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension | Drug | 4 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension | Drug | 5 |
| Formoterol FumarateInhalation Solution | Drug | 6 |
| PlaceboInhalation Solution | Drug | 7 |
Primary outcome
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
Time frame: 12 Weeks
1 secondary outcome
Incidence of adverse events (AEs)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Propionate/Formoterol Fumarate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by Dey at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.